Isotretinoin

Description

Isotretinoin is a medicine that is a naturally occurring derivative of vitamin A. It is used for the treatment of a severe form of acne called nodular acne characterized by large, inflamed, painful acne lesions deep under the skin. It acts on skin glands to reduce the production of a substance called sebum that can cause acne or pimples. It also has an anti-inflammatory action which decreases the redness and swelling associated with acne. This medicine is available in tablet, capsule, and gel dosage forms. Isotretinoin can cause some side effects like cracked lips, dry eyes, dryness of the nose, dry skin and mouth, nausea, vomiting and diarrhoea. It may cause skin sensitivity to sunlight so it is advised that you avoid going out in harsh sunlight or take precautions like sunscreen. Stop taking it if you experience severe allergic reactions like hives and difficulty in breathing. Isotretinoin should be taken with food or as prescribed by a doctor. It takes a few weeks to improve your symptoms, so you must complete the whole treatment even if you feel better after using a few doses. It is beneficial for you to have a balanced diet besides using Isotretinoin for its better result. Isotretinoin is not recommended to be used if you are pregnant and or breastfeeding. It may not be suitable for you if you have liver problems. It is not recommended for children under the age of 12 years. Avoid alcohol consumption while taking this medicine. Inform your doctor immediately if you experience serious side effects like changes in mood or depression, dizziness, ringing in ears, headache, problems with vision, pain behind the eyes, increased thirst and urination.

Side effects

Major & minor side effects for Isotretinoin

  • Bone and joint pain
  • Bleeding from nose
  • Scaling, burning, redness, and swelling of skin
  • Nausea and vomiting
  • Stomach pain
  • Diarrhoea
  • Pain and tenderness of eyes
  • Itchy and dry skin
  • Heart burn
  • Difficult or painful urination
  • Increased thirst
  • Increased heartbeat
  • Ringing or buzzing in the ears
  • Rectal bleeding
  • Changes in vision
  • Decrease/loss of hearing
  • Yellow colored eyes or skin
  • Increased sweating

Uses of Isotretinoin

What is it prescribed for?

  • Nodular acne
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Concerns

Commonly asked questions

  • Onset of action
    For oral forms (tablets, capsules): The amount of time required for Isotretinoin to show its action is 1-4 hours after taking it. For topical form (gel): The amount of time required for Isotretinoin to show its action is not known.
  • Duration of effect
    For oral forms (tablets, capsules): The time duration for which Isotretinoin remains effective is about 5 days (120 hours). For topical form (gel): The time duration for which Isotretinoin remains effective is not known.
  • Safe with alcohol?
    Avoid consumption of alcohol while taking Isotretinoin as it may cause unpleasant side effects such as rapid heartbeat, warmth or redness under your skin, tingly feeling, nausea, and vomiting.
  • Is it habit forming?
    No habit-forming tendencies were reported for Isotretinoin.
  • Usage in pregnancy?
    Isotretinoin is not recommended to be used in pregnancy as it can cause birth defects in your unborn child. Even a single dose of Isotretinoin can result in birth defects. Consult your doctor to know the risks and benefits of this medicine.
  • Usage while breast-feeding?
    Isotretinoin is not recommended to be used in breastfeeding as it may pass into breast milk. This can potentially harm your child. Consult your doctor to know the risks and benefits of this medicine.

Allergy

Avoid using Isotretinoin if you are allergic to isotretinoin or any other component present in this medicine. Seek medical help immediately if you notice any symptoms such as skin rashes, itching/swelling, dizziness, breathing difficulty, etc.

Severe liver disease

Isotretinoin is not recommended for use if you have severe liver conditions as it may worsen your condition.

Hypervitaminosis A

Hypervitaminosis A is a condition that occurs when you have too much vitamin A in your body. Symptoms of hypervitaminosis A include vision problems, changes in the skin, and bone pain. In such cases, Isotretinoin is not recommended for use as it is also a derivative of vitamin A and may worsen your condition.
Warnings for special population

Pregnancy

Isotretinoin is not recommended to be used in pregnancy as it can cause birth defects in your unborn child. Even a single dose of Isotretinoin can result in birth defects. Consult your doctor to know the risks and benefits of this medicine.

Breast-feeding

Isotretinoin is not recommended to be used in breastfeeding as it may pass into breast milk. This can potentially harm your child. Consult your doctor to know the risks and benefits of this medicine.
General warnings

Exposure to sun

The use of Isotretinoin may cause severe side effects on sun exposure. You are advised to stay away from sunlight until finishing the course of the treatment. Take appropriate precautionary measures like covering your skin, use high SPF sunscreen etc., before stepping out during treatment with this medicine.

Contraception

Isotretinoin can cause oral/hormonal contraceptive medicine failure, so the use of multiple contraceptive methods is advised. Appropriate means of birth control should be adopted while using Isotretinoin to avoid pregnancy.

Donation of blood

It is advised to refrain from donating blood for one month after stopping the use of Isotretinoin because of the potential risk to your unborn baby if you are a pregnant transfusion recipient.

Depression

Isotretinoin has been known to cause varying levels of depression. Report any current/past incidences of depression, agitation, anxiety, or psychotic condition to your doctor while on treatment with this medicine.

Hearing loss

The use of Isotretinoin has been associated with hearing loss which may persist even after the use is discontinued. You should immediately contact your doctor if you face any hearing issues.

Disturbance in vision

The use of Isotretinoin may cause dry eyes, decreased night vision and loss of transparency of cornea that could persist even after stopping the treatment. Contact your doctor immediately if you experience any issues with your vision.

Hyperlipidaemia

Hyperlipidaemia is a condition in which there are high levels of fat particles (lipids) in the blood. Isotretinoin has been associated with an increased level of lipids and triglycerides in the body and hence should be used with caution if you have Hyperlipidaemia and other associated problems. Your doctor may adjust the dose of this medicine if required based on your condition.

Driving or operating machinery

Isotretinoin may rarely cause dizziness, drowsiness, visual disturbances, etc. Do not perform any activities that require high mental alertness like driving vehicles or operating machines if you experience any of these symptoms after taking this medicine.

Diabetes

Isotretinoin may alter blood sugar levels and should be used with extreme caution if you have diabetes mellitus. Your doctor may advise suitable dose adjustments and regular monitoring of blood sugar levels or replacement with a suitable alternative based on your clinical condition.

Missed Dose

Oral forms (tablets, capsules): Do not skip a dose of Isotretinoin. If you forget to take a dose of this medicine, take it as soon as you remember. If it is time for your next dose, skip the missed one. Do not double the dose to compensate for the missed one. Gel: Apply the missed dose of Isotretinoin as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not apply a double dose to make up for the missed dose.

Overdose

Oral forms (tablets, capsules): Contact a doctor immediately if an overdose with this medicine is suspected. Symptoms of overdose may include a headache, dizziness, vomiting, stomach pain, tingling and stinging sensation of the skin etc. Gel: An overdose of this medicine is not likely to cause severe symptoms. However, the ingestion of this medicine may cause harm and immediate medical intervention may be required.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Avoid consumption of alcohol while taking Isotretinoin as it may cause unpleasant side effects such as rapid heartbeat, warmth or redness under your skin, tingly feeling, nausea, and vomiting.
Interaction with Medicine

Tetracycline

Ethinyl Estradiol

Methoxsalen

Natural Micronised Progesterone

Disease interactions

Intracranial hypertension

Isotretinoin is not recommended as it is associated with pseudotumor cerebri (when the pressure inside the skull increases). Early signs and symptoms include papilledema (Papilledema is swelling of your optic nerve, which connects the eye and brain), headache, nausea and vomiting, and visual disturbances.

Psychiatric disorders

Isotretinoin has been associated with causing depression, psychosis and an increase in suicidal behaviour. It should be administered cautiously and with supervision, if you have any preexisting psychiatric conditions or depression. Your doctor may adjust the dose of this medicine or suggest alternatives if required based on your condition.

Osteoporosis

Osteoporosis is a condition in which bones become weak and brittle. Isotretinoin may cause a reduction in bone density and hence should be used with caution if you have osteoporosis or other conditions affecting bone density. Your doctor may adjust the dose of this medicine or suggest alternatives if required based on your condition.

Liver disease

Isotretinoin should be used with extreme caution if you have liver problems as it is associated with elevations in liver enzymes and hepatitis (swelling of the liver). Your doctor may suggest tests to monitor your liver functioning and may adjust the dose of this medicine if required based on your condition.

Pancreatitis

Isotretinoin should be used with caution if you have a pancreatic problem as it may worsen your condition. Your doctor may suggest tests to monitor your pancreatic condition and may adjust the dose of this medicine if required based on your condition.
Food interactions
Information not available.
Lab interactions
Information not available.
Oral forms (tablets, capsules): Take Isotretinoin as instructed by the doctor. Follow all the directions mentioned on the label. Do not take more or fewer doses than prescribed. This medicine should be taken with food. The symptoms might get worse in the initial phase of treatment. Gel: Apply a thin layer of the gel to the affected area as instructed by the doctor. Follow all the usage instructions mentioned on the label or the package insert. Do not apply in larger or smaller quantities than recommended. Do not cover the application area with bandages or other coverings unless specifically instructed by the doctor.
Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works
Isotretinoin reduces sebum production on the face which prevents the blockage of pores of the skin. Since these pores are open, it is easier to clean out acne-causing bacteria from the skin. This prevents and controls acne breakouts.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Miscellaneous antineoplastics

Schedule

Schedule H

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https://medlineplus.gov/druginfo/meds/a681043.html>

Pile, H. and Sadiq, N., 2021. Isotretinoin. [online] Ncbi.nlm.nih.gov. Available at: < [Accessed 20 September 2021].

https://www.ncbi.nlm.nih.gov/books/NBK525949/>

Medicines.org.uk. 2021. Isotretinoin 20mg capsules - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 15 June 2021].

https://www.medicines.org.uk/emc/product/3870/smpc>

CiplaMed. 2021. ISOTROIN Capsules. [online] Available at: < [Accessed 15 June 2021].

https://www.ciplamed.com/content/isotroin-capsules>

Dailymed.nlm.nih.gov. 2021. DailyMed - ABSORICA- isotretinoin capsuleABSORICA LD- isotretinoin capsule. [online] Available at: < [Accessed 15 June 2021].

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ef0cff8-19c1-4441-b780-fca6c7ee1615>

Medicines.org.uk. 2021. [online] Available at: < [Accessed 15 June 2021].

https://www.medicines.org.uk/emc/files/pil.3870.pdf>

Accessdata.fda.gov. 2021. [online] Available at: < [Accessed 15 June 2021].

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf>

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Information on this page was last updated on 22 Oct 2021

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